Presenter

Shannon Hoste is the Chief Scientific Officer for Patient for Pathway Health and supports Human Factors Strategy with independent consulting through Hoste Consulting. Shannon has worked in the medical device and combination products space for 25+ years. Including four years as a Team Lead for Human Factors in FDA’s Center for Devices and Radiological Health (CDRH) and as reviewer within the Center for Drug Evaluation and Research (CDER). At the FDA she led reviews of Human Factors data for medical device premarket submissions through 510(k), PMA, and De Novo pathways; combination products through NDA, BLA, and ANDA pathways; as well as data to support IND and IDE requests. Shannon holds a BS in mechanical engineering, MS in business and an MS in Cognitive Systems Engineering.